K-number	K133565
Device name	LEKSELL GAMMA KNIFE PERFEXION
Applicant	Elekta Instrument AB
Product code	IWB
Device class	Class II
Decision date	May 9, 2014
Decision	Substantially Equivalent
Regulation	892.5750

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Source

View the full FDA submission: accessdata.fda.gov

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LEKSELL GAMMA KNIFE PERFEXION

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